82 Participants NeededMy employer runs this trial

PNMR for Post-COVID Syndrome

Recruiting at 3 trial locations
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Overseen BySamuel H. O. Bock / CSO, BA Environmental Science
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for individuals dealing with Long COVID, a condition where symptoms persist or emerge months after the initial infection. Participants will receive either a new treatment called Paragon Novel Metabolic Regulator (PNMR) along with standard care or just standard care for six weeks. The researchers aim to determine if PNMR can manage Long COVID symptoms more effectively than standard care alone. Individuals with a confirmed COVID-19 diagnosis who continue to experience symptoms three months after infection might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any over-the-counter supplements, vitamins, or natural products, as well as any medications that could affect fatigue and cognitive function during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies indicate that patients using Paragon Novel Metabolic Regulator (PNMR) have generally tolerated the treatment well, with few reports of side effects. Some individuals have experienced gas with a sulfur-like smell, signaling the body's adjustment to the treatment. Rarely, patients have reported unpleasant dreams, which may suggest a need for a lower dosage. This trial is in a phase that evaluates both safety and effectiveness, and earlier research suggested that PNMR is safe. However, as the treatment remains under investigation, researchers continue to learn about its safety for everyone.12345

Why do researchers think this study treatment might be promising for Long COVID?

The Paragon Novel Metabolic Regulator (PNMR) is unique because it targets post-COVID syndrome by focusing on the body's metabolic processes, specifically replenishing depleted sulfur protein nutrient stores essential for energy production and healing. Unlike standard treatments that typically manage symptoms with medications like corticosteroids or breathing exercises, PNMR potentially accelerates recovery by adjusting dosage based on individual healing signals, such as sulfur-smelling flatulence, which indicates the body's need for the active ingredient is decreasing. Researchers are excited about this treatment because it offers a personalized approach, allowing patients to tailor their dosage based on their body's signals, which could lead to more efficient and effective recovery from long COVID symptoms.

What evidence suggests that PNMR could be an effective treatment for Long COVID?

Research has shown that conditions like Long COVID link to changes in how the body uses energy and manages inflammation. Studies have found that these conditions cause noticeable shifts in these processes. In this trial, one group of participants will receive the Paragon Novel Metabolic Regulator (PNMR) along with dietary and lifestyle recommendations and standard care. Early results suggest that addressing these issues can improve symptoms for people with Long COVID, making PNMR a promising option for managing the condition.16789

Who Is on the Research Team?

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Sam Bock, BA Environmental Science

Principal Investigator

ParagonClinicals Inc CEO / CSO

Are You a Good Fit for This Trial?

This trial is for adults experiencing long COVID symptoms, such as mental fatigue, after recovering from COVID-19. Healthy volunteers may also participate. People with other serious health conditions or who do not meet the study requirements cannot join.

Inclusion Criteria

Negative COVID-19 test for a minimum of four weeks prior to enrollment
Women of childbearing potential must have a negative pregnancy test and willingness to use approved contraceptive methods during the study period
Willingness to adhere to study diet and exercise recommendations
See 8 more

Exclusion Criteria

I do not have any conditions that make vitamin D3 unsafe for me.
Subject with a vegetarian diet or unable to follow dietary guidelines
Known hypersensitivity to PNMR or its ingredients
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive PNMR + SOC or SOC alone for 6 weeks, with dietary and lifestyle recommendations

6 weeks
3 visits (in-person) at baseline, 3 weeks, and 6 weeks; 1 visit (telephone) at 4 weeks post-treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (telephone)

What Are the Treatments Tested in This Trial?

Interventions

  • Paragon Novel Metabolic Regulator (PNMR)

Trial Overview

The study compares a new treatment called Paragon Novel Metabolic Regulator (PNMR) plus standard care to standard care alone over six weeks. All participants receive dietary and lifestyle advice aimed at boosting immune function.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Group 2: Dietary and Lifetyle Recomendations + Standard of Care (SOC)Experimental Treatment1 Intervention
Group II: Group 1: PNMR + Dietary and Lifetyle Recomendations + Standard of Care (SOC)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

ParagonClinicals Inc.

Lead Sponsor

Citations

Evaluating the Safety and Efficacy of PNMR as Treatment ...

Patients will be treated with Paragon Novel Metabolic Regulator (PNMR) + standard of care (SOC) or SOC alone for 6 weeks for the treatment of ...

The Impact of Metabolic Syndrome on the Outcomes of ... - PMC

Substantial evidence supports the effectiveness of post-COVID-19 rehabilitation in enhancing physical performance, muscle strength, coordination, and mental ...

Systems Modeling Reveals Shared Metabolic ...

In a recently released preprint, OMF's computation team investigated the shared metabolic symptoms found in ME/CFS and Long COVID.

Metabolic signatures of post-viral syndromes: insights from ...

Together, these studies demonstrate that chronic post-viral syndromes are underpinned by measurable metabolic and inflammatory alterations, ...

Pycnogenol® in Post-COVID-19 Condition

Pycnogenol® may have potential to improve the health status of people suffering from post COVID-19 condition. This trial lasts for 12 weeks.

Long-COVID, Metabolic and Endocrine Disease - PMC

Initial studies have shown that people with overweight and diabetes mellitus have a higher risk of developing long-COVID associated symptoms.

Novel Clinical, Immunological, and Metabolic Features ...

This study investigates clinical, immunological, and metabolomic risk factors associated with post-acute COVID-19 syndrome (PACS) in 51 patients.

COVID-19 Research Literature - LibGuides

Clinical Trials (see more at the U.S. National Library of Medicine) · Evaluating the Safety and Efficacy of PNMR as Treatment for Long COVIDThis ...

Exploring metabolic anomalies in COVID-19 and post- ...

This study employs a novel approach utilizing machine learning (ML) and explainable artificial intelligence (XAI) to analyze metabolic alterations in COVID-19 ...